Title of Regulation: 12VAC5-31. Virginia Emergency Medical Services Regulations (amending 12VAC5-31-1140).

Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: November 5, 2014.

Effective Date: November 24, 2014.

Agency Contact: Michael Berg, Regulatory and Compliance Manager, Department of Health, 1041 Technology Park Drive, Glen Allen, VA 23059-4500, telephone (804) 888-9131, or email michael.berg@vdh.virginia.gov.

Basis: Chapters 191 and 328 of the 2013 Acts of Assembly amended § 54.1-3408 of the Code of Virginia permitting certified emergency medical services (EMS) personnel acting within their scope of practice to administer drugs and devices pursuant to an oral or written order or standing protocol. Before the Office of EMS (OEMS) could remove language in the Virginia Emergency Services Regulations (12VAC5-31) that requires EMS personnel to obtain the signature of the medical practitioner who assumes responsibility for the patient, the Board of Pharmacy had to first remove language pertaining to medical practitioner signature in its existing regulations in 12VAC110-20-500. The Board of Pharmacy met on June 18, 2013, and adopted changes in regulation that became effective September 25, 2013. Section 32.1-111.4 of the Code of Virginia provides the statutory authority for the State Board of Health to promulgate these regulations.

Purpose: Each licensed EMS agency is required to have an operational medical director (OMD) who meets specific criteria outlined in the EMS Regulations. Certified EMS providers work under the direction and authorization of the OMD to include performing medical procedures and drug administration. Requiring a medical practitioner to sign patient care reports (electronic or otherwise) documenting drug administration or procedures with which they may not be familiar is onerous to the emergency department practitioner and unnecessary. Approved patient care guidelines (protocols) already exist authorizing the EMS provider to perform the drug administration or medical procedure under the authorization of the OMD. There is documentation (medication administration record) that is part of the patient care report showing what is administered or performed and signed by the EMS provider. This action removes extra, unwanted demands on an already burdened medical practitioner in an emergency department, while maintaining a process that can be documented and establishes accountability and protects the health, safety, and welfare of patients.

Rationale for Using Fast-Track Process: This action eliminates unnecessary requirements and additional burdensome documentation for the medical practitioner. Key stakeholder groups and members of the EMS system support this change and no opposition is anticipated or has been voiced for this regulatory change.

Substance: The amendment removes subsection B of 12VAC5-31-1140, which requires the signature of the prescriber.

Emergency medical services providers are certified and authorized to administer drugs pursuant to the regulations of the State Board of Health and an oral or written order or standing protocol of their operational medical director. This amendment allows the EMS provider to document the administration of a drug or procedure as part of the "protocols" as established by their contracted OEMS-approved operational medical director. The drug administration documentation is supported by the Board of Pharmacy regulations (18VAC110-20-500). This amendment will reduce the amount of time an agency needs to be out of service to gain signatures prior to the exchanging of drug kits within facilities and returning the units back to service.

Issues: An advantage to the EMS unit and the public is that amending the identified regulation will permit a quicker "in-service" time for the unit to prepare for the next request for service. The time spent seeking a medical practitioner's signature for medication administration or a specific procedure only delays the in-service time for a response unit. Delays in returning EMS units to service can be particularly troubling in high volume systems or in a rural agency with limited resources trying to meet EMS call demands. There are no disadvantages to the public or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to eliminate the requirement to have a medical practitioner sign a patient care report (electronic or otherwise) attesting to the delivery of a drug or the performance of an invasive procedure when Emergency Medical Services (EMS) personnel administer drugs, perform invasive procedures or assist patients with their medications.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Each licensed EMS agency is required to have an Operational Medical Director (OMD) who meets criteria specified in the EMS Regulations. Certified EMS providers work under the direction and authorization of the OMD performing medical procedures and drug administration.

If an EMS provider caring for a patient determines that an invasive procedure is required and that a drug needs to be administered, they can do so under the authorization of the OMD. In most cases, the supplies needed for this action are from a drug kit supplied by the hospital, stocked by and sealed by the pharmacist-in-charge. Once this box is opened, there is documentation by the EMS provider noting the procedures and the drugs administered.

Under the current regulation, the EMS provider needs to track down the practitioner at the receiving facility to have them also sign the documentation. In the event the practitioner refuses to sign the document, the OMD would have 7 days to sign the documentation. Until the documentation is signed by the practitioner, the EMS agency cannot exchange the used kit for a new kit. Finding the practitioner to sign the form, then going to the pharmacy (which may not be on the same floor) can often add significant time before an ambulance at the facility is ready for service for the next call. This has led to ambulances waiting significant times at hospitals for staff to get signatures in order to exchange their drug kit, keeping the ambulances from potentially answering waiting calls for service.

The Board's proposal to eliminate the requirement to have a medical practitioner sign a patient care report attesting to the delivery of a drug or the performance of an invasive procedure when EMS personnel administer drugs, perform invasive procedures or assist patients with their medications would effectively reduce the amount of time an EMS agency at a hospital needs to be out of service to gain signatures prior to the exchanging of drug kits within facilities and returning the units back to service. Effectively this would eliminate unnecessary administrative time spent by the medical practitioner and unnecessary delays in ambulance availability without compromising patient care since the certified EMS providers do work under the direction of the OMD. Thus the proposal, if implemented, should create a net benefit.

Businesses and Entities Affected. The proposed amendment affects the 680 licensed Emergency Medical Services agencies in Virginia.¹

Localities Particularly Affected. The proposed amendment does not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendment is unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. According to data provided by the Virginia Department of Health, 78 of the 680 licensed Emergency Medical Services agencies are commercial entities. The proposed amendment will enable these firms to reduce delays in providing their services.

Small Businesses: Costs and Other Effects. Most of the 78 commercial licensed Emergency Medical Services agencies are likely small businesses. The proposed amendment will enable these firms to reduce delays in providing their services.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendment does not adversely affect small businesses.

Real Estate Development Costs. The proposed amendment does not significantly affect real estate development costs.

Legal Mandate. General: The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia and Executive Order Number 14 (2010). Section 2.2-4007.04 requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the report should include but not be limited to:

• the projected number of businesses or other entities to whom the proposed regulatory action would apply,

• the identity of any localities and types of businesses or other entities particularly affected,

• the projected number of persons and employment positions to be affected,

• the projected costs to affected businesses or entities to implement or comply with the regulation, and

• the impact on the use and value of private property.

Small Businesses: If the proposed regulatory action will have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include:

• an identification and estimate of the number of small businesses subject to the proposed regulation,

• the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents,

• a statement of the probable effect of the proposed regulation on affected small businesses, and

• a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation.

Additionally, pursuant to § 2.2-4007.1, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules (JCAR) is notified at the time the proposed regulation is submitted to the Virginia Register of Regulations for publication. This analysis shall represent DPB's best estimate for the purposes of public review and comment on the proposed regulation.

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¹ Data source: Virginia Department of Health (as of March 27, 2014)

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

The amendments eliminate the requirement to have a medical practitioner sign a patient care report (electronic or otherwise) attesting to the delivery of a drug or the performance of an invasive procedure by an emergency medical services provider.

12VAC5-31-1140. Provision of patient care documentation.

A. EMS personnel and EMS agencies shall provide the receiving medical facility or transporting EMS agency with a copy of the prehospital patient care report for each patient treated at the time of patient transfer. Should EMS personnel be unable to provide the full prehospital patient care report at the time of patient transfer, EMS personnel shall provide an abbreviated documented report with the critical EMS findings and actions at the time of patient transfer and the full prehospital patient care report shall be provided to the accepting facility within 12 hours.

B. The signature of the prescriber, as defined in § 54.1-3401 of the Code of Virginia, who assumes responsibility for the patient shall be included on the prehospital patient care report for an incident when a drug is administered, or self-administration is assisted (excluding oxygen), or an invasive procedure is performed. EMS personnel shall not infer that the prescriber's signature denotes approval, authorization or verification of compliance with protocol, standing orders or medical control orders.

The receiving prescriber signature requirement above does not apply to drugs that are maintained by EMS personnel during transport of patients between healthcare facilities, provided adequate documentation of ongoing drugs are transferred with the patient by the sending facility.

If a patient is not transported to the hospital or if the attending prescriber at the hospital refuses to sign the prehospital patient care report, the PPCR shall be signed by the agency's operational medical director within seven days of the administration and a signed copy delivered to the hospital pharmacy that was responsible for any drug kit exchange.